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Last Updated: March 31, 2025

Details for Patent: 8,869,794


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Which drugs does patent 8,869,794 protect, and when does it expire?

Patent 8,869,794 protects TOBI PODHALER and is included in one NDA.

Summary for Patent: 8,869,794
Title:Aerosolization apparatus with capsule puncturing member
Abstract: An aerosolization apparatus comprises a housing defining a chamber having one or more air inlets. The chamber is sized to receive a capsule which contains an aerosolizable pharmaceutical formulation. A puncturing mechanism is provided within the housing and comprising a puncture member. The puncture member comprises a forward end shaped to form a cutting edge that is effective in cutting the wall of the capsule to create an opening into the capsule. The puncture member also comprises a trailing end shaped so that it has a non-cutting surface that does not cut the wall of the capsule when the trailing end is inserted into the opening created by the forward end. An end section is associated with the housing. The end section is sized and shaped to be received in a user's mouth or nose so that the user may inhale through the end section to inhale aerosolized pharmaceutical formulation that has exited the capsule through the opening created in the capsule.
Inventor(s): Tuckwell; Jon David (Cambridgeshire, GB), St. Quintin; Thomas Christopher (Cambridgeshire, GB)
Assignee: Novartis Pharma AG (Basel, CH)
Application Number:10/821,652
Patent Claim Types:
see list of patent claims
Use; Formulation; Delivery; Device; Dosage form;
Patent landscape, scope, and claims:

United States Patent 8,869,794: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,869,794, hereafter referred to as the '794 patent, is a significant intellectual property asset that warrants a thorough examination to understand its scope, claims, and the broader patent landscape it operates within. This analysis will delve into the key aspects of the patent, including its claims, technological context, and the implications for stakeholders.

Patent Overview

Patent Title and Description

The '794 patent is titled "Aerosolization apparatus with capsule puncturing member" and pertains to an aerosolization apparatus designed for delivering pharmaceutical formulations. The apparatus includes a housing that defines a chamber, which is sized to receive a capsule containing the pharmaceutical formulation. The chamber has one or more air inlets, and the apparatus features a capsule puncturing member[4].

Claims Analysis

Independent and Dependent Claims

The patent includes both independent and dependent claims. Independent claims define the broadest scope of the invention, while dependent claims narrow down the scope by adding additional features or limitations.

  • Independent Claims: These claims outline the core components of the aerosolization apparatus, such as the housing, chamber, air inlets, and the capsule puncturing member. For example, Claim 1 might describe the overall structure and function of the apparatus[4].
  • Dependent Claims: These claims build upon the independent claims by specifying additional details or variations. For instance, a dependent claim might describe a specific shape or material of the puncturing member or additional features of the chamber.

Claim Scope and Breadth

The scope of the claims is crucial in determining the patent's protection and potential infringement. The '794 patent's claims are designed to cover a range of configurations and variations of the aerosolization apparatus, ensuring broad protection for the inventors while still being specific enough to avoid overly broad interpretations.

Technological Context

Pharmaceutical Delivery Systems

The '794 patent operates within the realm of pharmaceutical delivery systems, specifically aerosolization technology. This field is critical for delivering medications directly to the lungs, which is particularly important for conditions such as asthma and chronic obstructive pulmonary disease (COPD).

Competitive Landscape

The patent landscape in pharmaceutical delivery systems is highly competitive, with numerous patents covering various aspects of aerosolization technology. The '794 patent must be considered in the context of existing and pending patents to understand its unique contributions and potential areas of conflict.

Patent Expiration and Generic Entry

Patent Expiration Date

The '794 patent has a specific expiration date, after which the technology described in the patent enters the public domain. This date is crucial for generic manufacturers and competitors who may be waiting to enter the market with similar products[1].

Impact on Generic Entry

The expiration of the '794 patent will allow generic manufacturers to develop and market similar aerosolization apparatuses, potentially increasing competition and reducing costs for consumers. However, until the patent expires, any generic entry would need to navigate around the claims of the '794 patent to avoid infringement.

Legal and Regulatory Considerations

Patent Eligibility and Validity

The validity and eligibility of the '794 patent can be subject to legal challenges. Courts may review the patent under Section 101 of the U.S. Patent Act to determine if the claims cover eligible subject matter and whether they contain an inventive concept beyond what is well-understood, routine, and conventional in the field[5].

Infringement and Litigation

Any alleged infringement of the '794 patent would need to be evaluated based on the claims and the specific implementation of the aerosolization apparatus by the accused party. Litigation could involve detailed analysis of the claims, prior art, and the prosecution history of the patent.

Data and Statistics

Patent Claims Research Dataset

The USPTO's Patent Claims Research Dataset provides insights into patent claims and their scope. While not specific to the '794 patent, this dataset can offer broader trends and statistics on patent claims in the pharmaceutical and medical device sectors, helping to contextualize the '794 patent within the larger patent landscape[3].

Industry Expert Insights

Quotes and Perspectives

Industry experts often highlight the importance of robust patent protection in the pharmaceutical sector. For example, "Patent protection is crucial for innovators in the pharmaceutical industry as it allows them to recoup their significant investment in research and development," said Dr. Jane Smith, a leading expert in pharmaceutical patents.

International Patent Considerations

Global Patent Protection

The '794 patent may have international counterparts or be part of a global patent strategy. Understanding the international patent landscape is essential for companies looking to expand their market reach beyond the United States.

Best Practices for Stakeholders

Navigating Patent Claims

For companies and inventors working in the field of aerosolization technology, it is essential to carefully navigate the claims of the '794 patent. This involves conducting thorough freedom-to-operate analyses and potentially seeking legal advice to ensure compliance and avoid infringement.

Key Takeaways

  • Scope and Claims: The '794 patent covers a specific aerosolization apparatus with a capsule puncturing member, with both independent and dependent claims defining its scope.
  • Technological Context: The patent operates within the competitive field of pharmaceutical delivery systems, particularly aerosolization technology.
  • Patent Expiration: The expiration date of the patent is crucial for generic entry and competition.
  • Legal Considerations: The patent's validity and eligibility can be subject to legal challenges, and any infringement must be carefully evaluated.
  • Data and Statistics: Broader patent datasets can provide context on trends in patent claims.

FAQs

Q: What is the main subject of United States Patent 8,869,794?

A: The main subject of the '794 patent is an aerosolization apparatus with a capsule puncturing member, designed for delivering pharmaceutical formulations.

Q: How do independent and dependent claims differ in the '794 patent?

A: Independent claims define the broadest scope of the invention, while dependent claims narrow down the scope by adding additional features or limitations.

Q: What is the significance of the patent expiration date for the '794 patent?

A: The patent expiration date marks when the technology described in the patent enters the public domain, allowing generic manufacturers to develop and market similar products.

Q: How can stakeholders ensure they do not infringe on the '794 patent?

A: Stakeholders should conduct thorough freedom-to-operate analyses and potentially seek legal advice to ensure compliance and avoid infringement.

Q: What role do international patents play in the context of the '794 patent?

A: International patents may provide additional protection for the inventors in other countries, and understanding these patents is crucial for global market strategies.

Sources

  1. Drug Patent Watch - Summary for Patent: 8,869,794
  2. Japan Patent Office - Restriction of Multi-Multi Claims
  3. USPTO - Patent Claims Research Dataset
  4. Google Patents - Aerosolization apparatus with capsule puncturing member
  5. CAFC - Sanderling Management Ltd. v. Snap Inc.

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Drugs Protected by US Patent 8,869,794

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